Title: Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients With Cortisol-Secreting Adrenal Adenomas or Hyperplasia (GRADIENT): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant

RPN: IRB00250972

PI: Amir H. Hamrahian, MD

Adrenal glands are a pair of walnut-sized organs above the kidneys. They produce a number of hormones including cortisol. Adenomas or hyperplasia of the adrenal gland are non-cancerous (benign) growths on the adrenal gland. Most do not cause any signs or symptoms and some may produce excess hormones and require treatment. High levels of cortisol hormone can lead to complications such as obesity, diabetes, hypertension, hyperlipidemia, and osteoporosis.

The purpose of this study is to find out whether the investigational study drug, relacorilant which blocks cortisol action, is safe and effective in treating participants with excess cortisol caused by adrenal adenomas or adrenal hyperplasia. The study will look at how well relacorilant controls blood glucose and blood pressure level.

Because this is a scientific research study, it is also important to collect information about patients with adrenal adenoma/hyperplasia who are not receiving relacorilant. Therefore, relacorilant will be compared to “placebo”, which is an inactive material that does not contain any active study drug. All the patients who receive placebo will be offered the study drug, relacorilant after 22 weeks in the open phase of the study.

Male and female subjects who are 18 to 80 years old and have adrenal adenoma or hyperplasia are eligible for the study.

The use of relacorilant in this research study is investigational. The word “investigational” means that relacorilant is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of relacorilant in this study.

Participation in this study lasts about 32 weeks and includes 9 visits to the study site which occur every 2-4 weeks initially and then every 4 weeks. Participants will have some routine medical tests (physical exam, blood draw, and an electrocardiogram [ECG]) and will have to come to some visits fasting.

Any research has some risks. There may be adverse effects related to the study drug while taking part in the study, so everyone taking part in the study will be watched carefully. Information about risks is discussed in greater detail in the consent form.

Participants may or may not benefit as a result of participation in this study. Results from this study may benefit others in the future.

It will not cost anything to be in this study. Participants will be paid for the study visits completed to compensate for the time and inconvenience related to participation in this study.

Some of eligibility (inclusion) criteria for patients who may be interested in the study:

1. Male and female subjects 18 to 80 years old
2. Has a documented diagnosis of adrenal adenoma or hyperplasia

For more information, contact the study coordinator at 667-217-5528.

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